GE Medical Systems China Co., Ltd. FDA Record
- Latest inspection NAI · Jan 8, 2026
- 18 Class I recalls
- No warning letters matched by name
GE Medical Systems China Co., Ltd. has 27 FDA recalls (18 Class I), 3 inspections, 13 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GE Medical Systems China Co., Ltd." is on file.
- Latest recall
- Z-2306-2026 · Class II · Apr 21, 2026
- Latest inspection
- Jan 8, 2026 · NAI
- Latest 510(k)
- Nov 1, 2017
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 27 (18 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 13 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
GE Medical Systems China Co., Ltd.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 1 | 0 |
| 2025 | 0 | 0 | 0 | 20 | 18 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 3 | 0 |
| 2017 | 0 | 0 | 0 | 2 | 0 |
Reviewing GE Medical Systems China Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check GE Medical Systems China Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2306-2026 | Class II | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001… | Apr 21, 2026 |
| Z-0913-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1… | Nov 14, 2025 |
| Z-0914-2026 | Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1… | Nov 14, 2025 |
| Z-0915-2026 | Class I | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit… | Nov 14, 2025 |
| Z-2030-2025 | Class II | GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers… | May 16, 2025 |
| Z-2029-2025 | Class II | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound… | May 16, 2025 |
| Z-1638-2025 | Class I | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. | Mar 21, 2025 |
| Z-1636-2025 | Class I | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. | Mar 21, 2025 |
| Z-1625-2025 | Class I | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. | Mar 21, 2025 |
| Z-1633-2025 | Class I | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. | Mar 21, 2025 |
| Z-1635-2025 | Class I | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. | Mar 21, 2025 |
| Z-1624-2025 | Class I | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | Mar 21, 2025 |
| Z-1628-2025 | Class I | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. | Mar 21, 2025 |
| Z-1631-2025 | Class I | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. | Mar 21, 2025 |
| Z-1630-2025 | Class I | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. | Mar 21, 2025 |
| Z-1629-2025 | Class I | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. | Mar 21, 2025 |
| Z-1626-2025 | Class I | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. | Mar 21, 2025 |
| Z-1637-2025 | Class I | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. | Mar 21, 2025 |
| Z-1632-2025 | Class I | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. | Mar 21, 2025 |
| Z-1627-2025 | Class I | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. | Mar 21, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 8, 2026 | Wuxi, China | Devices | No Action Indicated (NAI) | 3003513129 |
| Feb 5, 2015 | Wuxi, China | Devices | Voluntary Action Indicated (VAI) | 3003513129 |
| Feb 16, 2012 | Wuxi, China | Devices | Voluntary Action Indicated (VAI) | 3003513129 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003513129 | Wuxi, China | 3 | Jan 8, 2026 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K171580 | Monitor B125, Monitor B105 | Nov 1, 2017 |
| K151063 | Monitor B40 | Dec 15, 2015 |
| K142288 | MAC 800 Resting ECG Analysis System | Dec 3, 2014 |
| K133576 | MONITOR B40 | Feb 21, 2014 |
| K130584 | MONITOR B40 | Jun 26, 2013 |
| K122253 | PROCARE MONITOR B20 | Mar 22, 2013 |
| K123238 | ACHILLES | Feb 25, 2013 |
| K120598 | PROCARE MONITOR B40 | Jul 19, 2012 |
| K103633 | ACHILLES | May 11, 2011 |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Oct 5, 2010 |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 |
| K091164 | GE VENUE 40, MODEL 5324338 | May 5, 2009 |
GE Medical Systems China Co., Ltd. and the FDA: common questions
Has GE Medical Systems China Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "GE Medical Systems China Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GE Medical Systems China Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "GE Medical Systems China Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GE Medical Systems China Co., Ltd.?
The most recent FDA inspection on file ended Jan 8, 2026 at Wuxi, China and was classified NAI. FDA has 3 inspections of GE Medical Systems China Co., Ltd. on file.
Has GE Medical Systems China Co., Ltd. had an FDA recall?
Yes. GE Medical Systems China Co., Ltd. has 27 FDA recalls on record, 18 of them Class I, the most serious class. The most recent started Apr 21, 2026.
Need more than this page shows? Ask about GE Medical Systems China Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.